"soon" is my favorite word. so vague yet assertive.
scorecarder listed all valid examples of how cytodyn got beat on the lopsided race to multiple finish lines. but what keeps me here and completely irks my inner soul is that leronlimab does better or as well as all those examples - with a far superior safety record. therefore we beat or had the potential to beat them all, if all real world factors were taken into account. but they werent. that changing though.
when is the FDA going to acknowledge that when a new drug is introduced that has similar or better results, but is far safer than SOC, that the new drug would be considered superior? it seems the FDA is completely ignoring this element, in our case, and may continue to do so. until they cant.
i also fully expect many more aduhelm scenarios to unfold under this administrations' clownshow, where this current "trend" of quicker approvals with less strenuous trial requirements has now begun to unfold, where a dangerous unsafe ineffective drug gets pushed through because of politics, money, and complete pharma-bro nonsense, and not actual data. makes me wonder will be getting ignored. this is not what we want. cytodyn is doing it the right way by the book.
"soon" - good data is coming, offers will be made, a BP will ride to glory, lives will be saved, off label use will open even more doors. in due time, patterson will have a vial in his shirt pocket, pestell will be a billionaire, and nader will poke his 3 fingers in someones eye and tell everyone i told ya so.. acceleration would be nice, but not remotely expected. so "soon" it is
scorecarder listed all valid examples of how cytodyn got beat on the lopsided race to multiple finish lines. but what keeps me here and completely irks my inner soul is that leronlimab does better or as well as all those examples - with a far superior safety record. therefore we beat or had the potential to beat them all, if all real world factors were taken into account. but they werent. that changing though.
when is the FDA going to acknowledge that when a new drug is introduced that has similar or better results, but is far safer than SOC, that the new drug would be considered superior? it seems the FDA is completely ignoring this element, in our case, and may continue to do so. until they cant.
i also fully expect many more aduhelm scenarios to unfold under this administrations' clownshow, where this current "trend" of quicker approvals with less strenuous trial requirements has now begun to unfold, where a dangerous unsafe ineffective drug gets pushed through because of politics, money, and complete pharma-bro nonsense, and not actual data. makes me wonder will be getting ignored. this is not what we want. cytodyn is doing it the right way by the book.
"soon" - good data is coming, offers will be made, a BP will ride to glory, lives will be saved, off label use will open even more doors. in due time, patterson will have a vial in his shirt pocket, pestell will be a billionaire, and nader will poke his 3 fingers in someones eye and tell everyone i told ya so.. acceleration would be nice, but not remotely expected. so "soon" it is
Quote:gilead slid in with approval b4 cytodyn had a chance to regroup on mdr-hiv. fda advised against it stating it was no longer an unmet need.
MASH / NASH went from "cytodyn reduces fibroris and nobody else" to "there are now a half dozen drugs reducing fibrosis in addition to having huge impacts on fatty deposits". that is why the pre-clinical data was good, but not good enough to proceed to additoonal trials.
hiv-PeEP was progressing well via 2 different pathways at OHSU - the AAV and standard leronlimab dosing - and then gileads massive PrEP trial basically closed the door entirely there. OHSU is now looking at Pep essentially, or really a different category of treatment altogether to eliminate reservoirs. its Pep for now though per their current design.
even the tnbc trials. they were well underway and trodelvy wasnt a thing yet. the 2 drugs were being trialed simultaneously and separately and therefore cytodyn didnt have a trodelvy trial cohort to compare against. trodelvy beat them to the punch and also more or less invalidated the cytodyn trials as far as being adequate to seek approval from those trials, which were then abandoned short of full enrollment.
they can still compete in tnbc, now that a new MOA was discovered with pd-1 expression. otherwise tnbc would be difficult to justify. you could argue against that for sure, but they were definitely set back by trodelvy.
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